As we noted in this article on PTAB Trial Insights, Senator Hatch (R-UT) has introduced the Hatch-Waxman Integrity Act, which is intended to restore the brand-generic balance many say has been skewed by Inter Partes Review and Post Grant Review proceedings. While the proposed legislation has been summarized as requiring generics to choose between ANDA litigation and IPR proceedings, it goes much further. If enacted, these amendments would require a choice between the ANDA/biosimilar approval pathway and challenging patents in patent office trial proceedings. Is that a real choice or would the law effectively shield pharmaceutical patents from IPR and PGR challenges?
On June 7, 2018, the USPTO issued a memorandum to the Examining Corps providing patent eligibility examination guidance based on the recent Federal Circuit decision in Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals. The Vanda memo emphasizes that method of treatment claims can be found to satisfy 35 USC § 101 at the first step of an Alice/Mayo analysis, without requiring a showing of “nonroutine or unconventional steps.”
In Droplets, Inc. v. E*Trade Bank, the Federal Circuit affirmed the decision of the USPTO Patent Trial and Appeal Board (PTAB) that Droplet’s patent was not entitled to the priority date of a provisional application because of a defect in the priority claim. In so doing, the court held that the statutory requirement for a “specific reference” to an earlier application cannot be satisfied by an incorporation by reference of another application that includes the specific reference at issue.
In Praxair Distrib., Inc. v. Mallinckrodt Hospital Prods. IP Ltd., the Federal Circuit found that the printed matter doctrine applies equally to physically embodied information and mental steps, and can be invoked in the patent eligibility context under 35 USC § 101 or the patentability context under 35 USC §§ 102 and 103. Does the court’s holding raise another hurdle to patent eligibility, or might the printed mater doctrine provide an avenue for consideration of mental steps in a diagnostic or personalized medicine method claim?
Several important changes to Bayh-Dole Act implementing regulations took effect on May 14, 2018, that will apply to funding agreements executed after that date and may apply to existing funding agreements modified after that date. In this article, we focus on the most significant patent-related changes.